Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG045157-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled trial (RCT) of the effectiveness of cognitive and exercise training versus control condition on cognitive function in older adults with mild cognitive impairment (MCI).
Exercise and cognitive training hold promise for delaying progression of MCI. Exercise improves cognitive ability, brain function, and brain structure in older adults. Cognitive training has been shown to durably improve mental abilities and functional status in older adults. In addition, persons with MCI respond to some forms of cognitive training just as robustly as healthy older adults.
This pilot study is a 4 group design with a home-based multi-modal physical exercise intervention, cognitive training, combined cognitive and physical training, and a social contact control enrolling older adults with MCI.
This pilot study is designed to be consistent with current recommended approaches to establishing trial feasibility. If the aims are achieved, it will provide a conceptual and practical rationale to support a large, multi-site, randomized clinical trial to test the efficacy of combined physical and cognitive training in delaying time to a clinical diagnosis of dementia.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Cognitive and Physical | Experimental | This consists of 45 minutes of Cognitive arm + 45 minutes of Physical arm (90 minutes total), 3 days a week for 12 weeks (36 sessions). |
|
| Cognitive | Active Comparator | This consists of 45 minutes of cognitive modules from Posit Science, 3 days a week for 12 weeks (36 sessions). |
|
| Physical | Active Comparator | This consists of 45 minutes of multi-modal physical exercise, 3 days a week for 12 weeks (36 sessions). |
|
| Active Control | Active Comparator | This consists of 45 minutes of group discussion of health and successful aging, 2 days a week for 12 weeks (24 sessions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Cognitive and Physical | Behavioral | Combined modules provide Cognitive training from Posit Science designed to improve information processing speed, learning, memory, and attention, and Physical training focused on seated aerobic and progressive resistance exercises designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function composite score as measured by individually-administered tests of psychomotor speed, complex sequencing, and list learning. | The cognitive composite is derived from: WAIS-IV Symbol Search, Trail Making Test Part B, and Rey Auditory Verbal Learning Test. | End of treatment at 12-weeks. |
| Average participant self-ratings of intervention acceptability. | Average of individual Likert self-ratings of the interventions (where 1 = very unenjoyable, 2 = not enjoyable, 3 = neutral, 4 = enjoyable, and 5 = very enjoyable) for each session of the 12-week intervention. | From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first. |
| Participant adherence to treatment. | Number of training sessions attended divided by the the total number of sessions available. | From date of randomization until the date of the final training session or the end of the 12-week intervention, whichever came first. |
| Participant adherence to outcome assessment. | Number of participants completing the post-training outcome assessment divided by the total number randomized. | End of treatment at 12-weeks. |
| Number of participants with study-related adverse events (AE) by treatment arm. | From enrollment through end of treatment at 12-weeks. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederick W Unverzagt, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cognitive | Behavioral | Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention. |
|
| Physical | Behavioral | Physical modules are focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults. |
|
| Active Control | Behavioral | Control modules provide social contact for group discussion of health and successful aging. |
|